Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT02264951
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat-induced Release of GLP-1 in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005830', 'term': 'tributyrin'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma GLP-1', 'timeFrame': '2 hours postprandial'}, {'measure': 'plasma GIP', 'timeFrame': '2 hours postprandial'}], 'secondaryOutcomes': [{'measure': 'plasma insulin', 'timeFrame': '2 hours postprandial'}, {'measure': 'plasma PYY', 'timeFrame': '2 hours postprandial'}, {'measure': 'plasma glucose', 'timeFrame': '2 hours postprandial'}, {'measure': 'plasma neurotensin', 'timeFrame': '2 hour postprandial'}, {'measure': 'plasma CCK', 'timeFrame': '2 hour postprandial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Short fatty acids', '2-oleoyl glycerol', 'GLP-1 secretion', 'C8-diet oil', 'GIP secretion'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '26178726', 'type': 'DERIVED', 'citation': 'Mandoe MJ, Hansen KB, Hartmann B, Rehfeld JF, Holst JJ, Hansen HS. The 2-monoacylglycerol moiety of dietary fat appears to be responsible for the fat-induced release of GLP-1 in humans. Am J Clin Nutr. 2015 Sep;102(3):548-55. doi: 10.3945/ajcn.115.106799. Epub 2015 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of 20 ml olive oil on a molar basis in human volunteers.', 'detailedDescription': 'A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG), may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty acid receptors.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian healthy male subjects\n* Body mass index (BMI) 19 to 25 kg/m2\n* Informed consent\n\nExclusion Criteria:\n\n* Anaemia\n* Diabetes mellitus\n* Gastrointestinal diseases or operations interacting with intestinal absorption'}, 'identificationModule': {'nctId': 'NCT02264951', 'briefTitle': 'Fat-induced Release of GLP-1 in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Short Fatty Acids-induced Release of GLP-1 in Humans', 'orgStudyIdInfo': {'id': 'SFAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A meal containing carrot and tributyrin', 'description': 'A meal containing 200 g grated carrot and 0.0216 mol tributyrin; blood test taken from 0 - 2 hours postprandial', 'interventionNames': ['Dietary Supplement: Tributyrin', 'Dietary Supplement: Carrot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A meal containing carrot and C8-diet oil', 'description': 'A meal containing 200 g grated carrot and 0.0216 mol of C8-diet oil; blood test taken from 0 - 2 hours postprandial', 'interventionNames': ['Dietary Supplement: C8-diet oil', 'Dietary Supplement: Carrot']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A meal containing carrot and olive oil', 'description': 'A meal containing 200 g grated carrot and 0.0216 mol of olive oil; blood test taken from 0 - 2 hours postprandial', 'interventionNames': ['Dietary Supplement: Olive oil', 'Dietary Supplement: Carrot']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A meal containing carrot', 'description': 'A meal containing 200 g grated carrot; blood test taken from 0 - 2 hours postprandial', 'interventionNames': ['Dietary Supplement: Carrot']}], 'interventions': [{'name': 'Tributyrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a triglyceride containing three C4-acids', 'armGroupLabels': ['A meal containing carrot and tributyrin']}, {'name': 'C8-diet oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position', 'armGroupLabels': ['A meal containing carrot and C8-diet oil']}, {'name': 'Olive oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'a triglyceride containing mostly three oleic acids', 'armGroupLabels': ['A meal containing carrot and olive oil']}, {'name': 'Carrot', 'type': 'DIETARY_SUPPLEMENT', 'description': 'mainly water and glucose', 'armGroupLabels': ['A meal containing carrot', 'A meal containing carrot and C8-diet oil', 'A meal containing carrot and olive oil', 'A meal containing carrot and tributyrin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jens J Holst, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Biomedical Sciences, University of Copenhagen'}, {'name': 'Mette J Mandøe, Student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup Hospital; Biomedical Sciences, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Katrine Bagge Hansen', 'investigatorAffiliation': 'Glostrup University Hospital, Copenhagen'}}}}